Business Development, West Coast
CurrentSmart Consulting Group provides strategic services to the biotechnology industry, the pharmaceutical industry, the medical device industry and the biologics industry.We use Lean manufacturing principles to drive efficiencies in client companies. We mix a modern Quality Systems approach and Risk Management to drive regulatory compliance. Our consultants have personal expertise in Laboratories design and LEAN operation, Process Development; Fermentation, Cell Culture and Bioreactor design and operations. We provide: • Custom tailored, solutions-based programs as we help streamline operations and compliance programs for greater productivity and profits.• Modern efficient production strategies for medical products with experience in: biopharmaceuticals, biologics, sterile drugs, solid dosage forms, medical devices/combination products and vaccines.• Lean manufacturing strategies for device type products such as skin patches and scaffold based products being developed for regenerative medicine purposes.• Evaluation of new processes and operational methodology.• Key ideas for remediation of bioprocess contamination situations such as for vaccines and other biological products. • Preventive maintenance measures /programs. • Key Quality related advice and impact programs for problem resolution.• Coordination of the company strategic Quality Program, emphasizing Lean Compliance with all processes. • Integration of Lean Laboratory with Lean Manufacturing operations. • Numerical and costing analysis for Life Sciences processes.Support of Interim Monitor activities of Federal Trade Commission Anti-Trust Group
